Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

NCT07170917 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: DRI192202025-522333-61-00U1111-1318-3453
• Study Type: interventional
• Target: 208
• Locations: 18 countries
• Sites: 69

Brief Summary

This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa. The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS. Study details include: The study duration (per participant) will be up to approximately 60 weeks for participants not transitioning into the long-term extension (LTE) study and will be up to approximately 52 weeks for participants transitioning into the LTE study. The randomized treatment duration will be up to approximately 48 weeks.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

  Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.

  Up to Week 16

Secondary Outcomes (10)

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

  Up to Week 16

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)

  Up to Week 16

• Change from Baseline in draining tunnel count at Week 16.

  From Baseline to Week 16

• Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16

  From Baseline to Week 16

• Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8

  From Baseline to Week 8

Study Arms (4)

Brivekimig dose regimen A

EXPERIMENTAL

Participants will receive Brivekimig dose regimen A.

Drug: Brivekimig

Brivekimig dose regimen B

EXPERIMENTAL

Participants will receive Brivekimig dose regimen B.

Drug: Brivekimig

Brivekimig dose regimen C

EXPERIMENTAL

Participants will receive Brivekimig dose regimen C.

Drug: Brivekimig

Placebo

PLACEBO COMPARATOR

Participants will receive Brivekimig matching placebo.

Drug: Placebo

Interventions

Brivekimig DRUG

* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

Also known as: SAR442970

Brivekimig dose regimen A; Brivekimig dose regimen B; Brivekimig dose regimen C

Placebo DRUG

* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
• Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
• Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
• Participants must be either biologic-naive or biologic-experienced.
• Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit.
• Participant must have a draining tunnel count of ≤20 at the Baseline visit.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
• History of recurrent or recent serious infection
• Known history of significant immunosuppression
• History of solid organ transplant or stem cell transplant
• History of splenectomy
• History of moderate to severe congestive heart failure.
• History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
• Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
• History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol
• Active suicidality and therefore significant suicide risk, as judged by the Investigator
• A history of an Adverse Event (AE) attributed to or related to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
• History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (69)

Northridge Clinical Trials - Northridge- Site Number : 8400005

Northridge, California, 91325, United States

RECRUITING

FXM Clinical Research - Miami- Site Number : 8400017

Miami, Florida, 33175, United States

RECRUITING

FXM Clinical Research Miramar, LLC - Site Number: 8400004

Miramar, Florida, 33027, United States

RECRUITING

Advanced Medical Research - Atlanta- Site Number : 8400011

Atlanta, Georgia, 30342, United States

RECRUITING

Georgia Skin & Cancer Clinic- Site Number : 8400009

Savannah, Georgia, 31419, United States

RECRUITING

The Iowa Clinic West Des Moines Campus- Site Number : 8400007

West Des Moines, Iowa, 50266, United States

RECRUITING

Louisiana Dermatology Associates- Site Number : 8400006

Baton Rouge, Louisiana, 70809, United States

RECRUITING

JDR Dermatology Research - Site number: 8400012

Las Vegas, Nevada, 89145, United States

RECRUITING

Clinical Partners- Site Number : 8400002

Johnston, Rhode Island, 02919, United States

RECRUITING

AMR Clinical South Strand, South Carolina- Site Number : 8400018

Myrtle Beach, South Carolina, 29588, United States

RECRUITING

Alpine Research Association- Site Number : 8400008

Layton, Utah, 84041, United States

RECRUITING

Investigational Site Number: 0360001

Liverpool, New South Wales, 2170, Australia

RECRUITING

Alfred Hospital - Site Number: 0360002

Melbourne, Victoria, 3004, Australia

RECRUITING

Interior Dermatology Centre - Site Number: 1240003

Kelowna, British Columbia, V1W 4V5, Canada

RECRUITING

Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc.

Hamilton, Ontario, L8L 3C3, Canada

RECRUITING

Investigational Site Number : 1240009

Toronto, Ontario, M4E 1R7, Canada

RECRUITING

Investigational Site Number: 1240005

Québec, Quebec, G1W 4R4, Canada

RECRUITING

Park Dermatology - Site number: 1240007

Sherwood Park, T8H 0P1, Canada

RECRUITING

Investigational Site Number: 1520003

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

RECRUITING

Investigational Site Number: 1520002

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

RECRUITING

Investigational Site Number: 1520001

Santiago, Reg Metropolitana de Santiago, 8380465, Chile

RECRUITING

Investigational Site Number: 1520005

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

RECRUITING

Investigational Site Number : 1560002

Chengdu, 610041, China

RECRUITING

Investigational Site Number : 1560001

Guangzhou, 510018, China

RECRUITING

Investigational Site Number : 1560005

Ürümqi, 830001, China

RECRUITING

Investigational Site Number: 2030002

Ostrava, 702 00, Czechia

RECRUITING

Investigational Site Number: 2030003

Ostrava, 708 52, Czechia

RECRUITING

Investigational Site Number: 2030001

Prague, 110 00, Czechia

RECRUITING

Investigational Site Number: 2030004

Prague, 150 06, Czechia

RECRUITING

Investigational Site Number: 2500001

Antony, 92160, France

RECRUITING

Investigational Site Number: 2500004

Bezannes, 51430, France

RECRUITING

Investigational Site Number : 2500003

Bordeaux, 33000, France

RECRUITING

Investigational Site Number : 2500002

Lyon, 69003, France

RECRUITING

Investigational Site Number : 2500006

Saint-Priest-en-Jarez, 42270, France

RECRUITING

Investigational Site Number: 2500007

Toulouse, 31059, France

RECRUITING

Investigational Site Number : 2760002

Bochum, 44791, Germany

RECRUITING

Investigational Site Number : 2760008

Bramsche, 49565, Germany

RECRUITING

Investigational Site Number : 2760003

Frankfurt, 60590, Germany

RECRUITING

Investigational Site Number : 2760005

Kiel, 24105, Germany

RECRUITING

Investigational Site Number : 2760004

Mainz, 55131, Germany

RECRUITING

Investigational Site Number : 2760001

Münster, 48149, Germany

RECRUITING

Investigational Site Number : 2760006

Würzburg, 97080, Germany

RECRUITING

Investigational Site Number : 3000001

Athens, 161 21, Greece

RECRUITING

Investigational Site Number : 3000005

Athens, 161 21, Greece

RECRUITING

Investigational Site Number : 3000004

Thessaloniki, 564 29, Greece

RECRUITING

Site Number: 3480001

Debrecen, Gangwon-do, 4032, Hungary

RECRUITING

Investigational Site Number: 3480003

Pécs, 7632, Hungary

RECRUITING

Investigational Site Number : 3480004

Székesfehérvár, 8000, Hungary

RECRUITING

Investigational Site Number: 3760002

Jerusalem, 9112001, Israel

RECRUITING

Investigational Site Number: 3760001

Tel Aviv, 6423906, Israel

RECRUITING

Investigational Site Number: 3800002

Milan, Milano, 20122, Italy

RECRUITING

Istituto Dermatologico San Gallicano, IRCCS - Site Number : 3800004

Roma, 00144, Italy

RECRUITING

Meiwa Hospital

Nishinomiya, Hyōgo, 663-8186, Japan

RECRUITING

University of the Ryukyus Hospital - Site Number: 3920002

Nishihara, Okinawa, 903-0215, Japan

RECRUITING

Nihon University Itabashi Hospital

Tokyo, 173-8610, Japan

RECRUITING

Investigational Site Number : 5280002

Groningen, 9713 GR, Netherlands

RECRUITING

Investigational Site Number: 6160001

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

RECRUITING

Investigational Site Number: 6160003

Lodz, Lódzkie, 90-265, Poland

RECRUITING

Investigational Site Number: 6160002

Warsaw, Masovian Voivodeship, 02-507, Poland

RECRUITING

Grupo Dermatologico de Carolina- Site Number : 8400023

Carolina, 00985, Puerto Rico

RECRUITING

Investigational Site Number: 7240006

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

RECRUITING

Investigational Site Number: 7240003

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

RECRUITING

Investigational Site Number: 7240002

Manises, Valencia, 46940, Spain

RECRUITING

Investigational Site Number: 7240004

Cadiz, 11009, Spain

RECRUITING

Investigational Site Number : 7240007

Granada, 18014, Spain

RECRUITING

Investigational Site Number: 7240005

Madrid, 28007, Spain

RECRUITING

Investigational Site Number: 7240001

Madrid, 28046, Spain

RECRUITING

Investigational Site Number : 8260008

London, England, E1 1BB, United Kingdom

RECRUITING

Investigational Site Number : 8260006

Leeds, LS9 7TF, United Kingdom

RECRUITING

Related Links

• DRI19220 Plain Language Results Summary

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): April 27, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (2); NL (1); FR (6); CN (3); CA (5); ES (7); AU (2); PL (3); JP (3); CZ (4); DE (7); GB (2); US (11); HU (3); GR (3); PR (1); CL (4); IL (2)